Gemfibrozil
NDC Package 50436-6540-4

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Gemfibrozil is used along with a proper diet to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. Marketed by Unit Dose Services, this product is identified by NDC 50436-6540 and is authorized under FDA application ANDA075034.

Identification & Billing

NDC Package Code
50436-6540-4
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
50436-6540
11-Digit Billing Format
50436654004

Clinical Specifications

Proprietary Name
Gemfibrozil
Dosage Form
-
Usage Information
Gemfibrozil is used along with a proper diet to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. It may also help to lower "bad" cholesterol (LDL). Gemfibrozil belongs to a group of drugs known as "fibrates." It works by decreasing the amount of fat produced by the liver. Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, gemfibrozil might not lower your risk of a heart attack or stroke. Talk to your doctor about the risk and benefits of gemfibrozil. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, drinking less alcohol, losing weight if overweight, and stopping smoking.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA075034
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-1998
End Marketing Date
12-31-2017
Listing Expiration
12-31-2017
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50436-6540). Click a package code to view its specific billing and regulatory data.

50436-6540-2
30 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50436-6540-4 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Gemfibrozil, labeled by Unit Dose Services. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Unit Dose Services on October 01, 1998. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Gemfibrozil is used along with a proper diet to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. It may also help to lower "bad" cholesterol (LDL). Gemfibrozil belongs to a group of drugs known as "fibrates." It works by decreasing the amount of fat produced by the liver. Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, gemfibrozil might not lower your risk of a heart attack or stroke. Talk to your doctor about the risk and benefits of gemfibrozil. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, drinking less alcohol, losing weight if overweight, and stopping smoking.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436654004. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
50436-6540-4
11-Digit CMS (5-4-2)
50436-6540-04

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.